What is a Biopharmaceutical, Part 1:
(Bio)Technology-Based Definitions - This reviews the four very different basic views/paradigms/definitions of what is a biopharmaceutical, concentrating on
technology-based definitions, e.g., biopharmaceuticals being pharmaceuticals manufactured using
biotechnology, and terms and definitions used by U.S. and European regulatory authorities.

What is a Biopharmaceutical, Part 2:
Company and Industry Definitions - This reviews and critiques the views/paradigms/definitions of biopharmaceutical no longer linked to or
involving biotechnology, with these aberrant definitions often adopted by many
in the financial community, press, companies (biopharma wannabees), and even the major U.S. trade associations (BIO and PhRMA).

Some major points:

A basic presumption of the author and the great majority of others in the industry (>85% in a recent survey), particularly in the U.S.,
is that biopharmaceutical is a subset of pharmaceutical, i.e., that biopharmaceuticals are
pharmaceuticals inherently (usually, very obviously) biological in nature and manufactured using biotechnology (involving use of live organisms),
while drugs comprise the other major subset of pharmaceuticals, with their source and manufacture being chemical (non-biological) in nature.

Small molecule and other drugs are not biopharmaceuticals!

Despite its definition and use being rather clear to most, there are many diverse definitions and views of what is (and is not) a biopharmaceutical
(and biotechnology).

Many outside the industry, including many in the financial community and press/media, and many within the pharmaceutical and biotechnology
industries, including the major U.S. biotechnology and pharmaceutical
trade associations (BIO, PhRMA), purposely redefine and use the term much more broadly,
ignoring or even disavowing linkage to or involvement with biotechnology, and almost always with little or no consistency. Caution! Many promulgating these abberant views/paradigms/definitions of what is biopharmaceutical (and biotechnology) seek to rebrand and redefine these products, the industry and themselves to promote their own vested interests.

Four major views, definitions or paradigms of biopharmaceutical are identified:

Broad Biotechnology - Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology
methods, with the products obviously having biological sources, usually involving live organisms or their
active components (bioprocessing; also usually very obvious; or directly involving surrogates, e.g., protein/gene sequences). This broad view has been adopted by Biopharmaceuticals in the U.S. and European Markets,
which includes all recombinant proteins, (monoclonal) antibodies, vaccines, blood/plasma-derived products,
nonrecombinant culture-derived proteins, and cultured cells and tissues. This is the view/definition most
used/favored by those within the U.S. biopharmaceutical industry, and probably best understood by the public.

New Biotechnology - This view or definition only includes those products based on platform technologies developed in
recent decades, usually only including recombinant proteins and monoclonal antibodies as being biopharmaceuticals, leaving out
nonrecombinant cultured proteins, blood/plasma proteins, vaccines and other classes of products.
This view/definition is more predominant in Europe, e.g., European Union formal definitions, or is used by those whose
primary/sole interest is in recombinant and monoclonal antibody products. Many obvious biopharmaceutical products are classed as
as 'old' or simply ignored, including many products developed and approved recently and incorporating more
recent/newer technology than many recombinant proteins and monoclonal antibodies (which are based on now 'old' technologies,
invented in the 1970s and commercialized in the 1980s).

Biotechnology Business - This company-centric view or definition simply includes all/everything from biotech-like (smaller, entrepreneurial, R&D-intensive) pharmaceutical and life science companies as being biopharmaceutical; plus obvious
biopharmaceuticals from large
companies (Big Pharma). All/every non-Big Pharma pharmaceutical or life sciences company is viewed as a biopharmaceutical company. By this view/definition,
products, technologies and companies need not have any involvement or use of
biotechnology to be called biopharmaceutical. Those using this
definition/view include many in the press, stock analysts and, regrettably, the Biotechnology Industry Organization (BIO). Many small drug R&D and
service companies
also describe themselves as biopharmaceutical companies, including those designing or developing small molecule drugs, even when their products,
technologies and companies
have absolutely no use or involvement with biotechnology.

Pharma Business - This view simply includes all pharmaceuticals as biopharmaceuticals, i.e., biopharmaceuticals is used as a synonym for pharmaceuticals; and the
pharmaceutical industry is now the biopharmaceutical industry. Biopharmaceuticals are no longer a subset of pharmaceuticals, with biopharmaceuticals now
taking in all pharmaceutical and (Boolean OR) biotechnology companies (with a health care orientation). Much of this (mis)use may be traceable to
what this author views as the
myth of convergence. Various industry analytical reports, including those funded and issued by the Pharmaceutical Research and
Manufacturers Association (PhRMA), assert that the pharmaceutical industry (dominated by Big Pharma) has just recently morphed or transformed itself into
the biopharmaceutical
industry as a result of the "convergence" of biotechnology and pharmaceutical industries/technologies; that the pharmaceutical industry,
through adoption of new technologies and close relationships (primarily outsourcing, contracting and licensing) with biotech companies, has undergone a
fundamental change; and that 'new' and 'revolutionary'
technologies, e.g., high-throughput screening and drug design methodologies, are biotechnologies and have fundamentally changed the industry. [Thus, everything in the pharmaceutical universe is now biopharmaceutical].

This author disagrees with the later three views, particularly the Biotech and Pharma Business views/paradigms/definitions. These simply consider to be biopharmaceutical (or biotechnology)
all/anything involving
small, R&D-intensive biomedical or life sciences (biotech-like) companies or related high-tech R&D; or all/anything pharmaceutical. Even the lay public understands that biopharmaceuticals involve biotechnology!

Abstract: The concepts, paradigms, terminology and definitions concerning generic biopharmaceuticals (biogenerics) are still in a primitive state, and anarchy and chaos prevail. Use of essentially all current terms may support, denigrate or obfuscate various views and discussions of the topic, e.g., to many 'generic' (and biogeneric) evokes negative connotations from association with generic drugs and/or suggests that products are identical, rather than similar/related.
There are three basic views/paradigms/definitions of generic biopharmaceuticals. Entity-based views concentrate on the products and active agents, including chemical structures and the unique aspects imparted by their biological source/identity, manufacturing process and specifications (process=product paradigm). Regulatory-based views concentrate on biopharmaceuticals as being approved or on track for approval as biogenerics (involving abbreviated filings based on comparative testing, sometimes therapeutic equivalence/substitution). Market/commercial-based views concentrate on products as competing for similar/same indications, having similar names, or any other perceived similarities. Depending on the view/paradigm/definition used and whether one takes a world or just Western (major market)-centric view, there are currently either many (hundreds), some or just a few biogeneric products in commerce; and biogenerics have either been around for a century or more, a few decades, a few years or do not yet even exist.

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